Epicardial Anchor Devices And Methods

ABSTRACT

Apparatus and methods are described herein for anchoring a prosthetic heart valve. In some embodiments, an apparatus includes a tether attachment member that includes a base member that defines at least a portion of a tether passageway through which a portion of a tether extending from a prosthetic heart valve can be received therethrough. The base member defines a locking pin channel that intersects the tether passageway. A locking pin is disposable within the locking pin channel and movable between a first position in which the locking pin is at a spaced distance from the tether passageway, and a second position in which the locking pin intersects the tether passageway and can engage the portion of a tether disposed therein to secure the tether to the tether attachment member.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.15/001,727, filed Jan. 20, 2016, which is continuation under 35 U.S.C. §120 of International Application No. PCT/US2014/049218, filed Jul. 31,2014, entitled “Epicardial Anchor Devices and Methods,” which claimspriority to and the benefit of U.S. Provisional Patent Application No.61/861,356, filed Aug. 1, 2013, entitled “Pursestring Epicardial PadDevice,” and. U.S. Provisional Patent Application No. 61/895,975, filedOct. 25, 2013, entitled “Improved Epicardial Pad Device,” each of thedisclosures of which is incorporated herein by reference in itsentirety. International Application No. PCT/US2014/049218 is also acontinuation-in-part of U.S. patent application Ser. No. 14/224,764,filed Mar. 25, 2014, entitled “Pursestring Epicardial Pad Device,” whichclaims priority to and the benefit of U.S. Provisional PatentApplication No. 61/861,356, filed Aug. 1, 2013, entitled “PursestringEpicardial Pad Device,” each of the disclosures of which is incorporatedherein by reference in its entirety.

BACKGROUND

Embodiments are described herein that relate to devices and methods foranchoring a medical device such as a prosthetic heart valve replacement.

Some known devices for anchoring a medical device, such as, for example,a prosthetic heart valve (e.g. mitral valve) can include securing one ormore tethers extending from the medical device to body tissue. Forexample, one or more tethers can extend from a prosthetic heart valvethrough an opening in the ventricular wall of the heart. Some knownmethods of anchoring or securing the tethers can include the use ofstaples or other fasteners that engage or pierce tissue near thepuncture site. Such devices can have relatively large profiles and bedifficult to easily deliver percutaneously to the desired anchoringsite. Some known methods of securing a prosthetic heart valve caninclude suturing the tethers extending from the valve to body tissue, ortying the suture ends. Such devices and methods can be difficult tomaneuver to secure the tether(s) with a desired tension,

Further, when an opening is made directly into the ventricular wall orapex of a heart, such as when a prosthetic valve is percutaneouslydelivered and deployed, in addition to securing the prosthetic valve ina proper position, the efficacy of sealing the puncture site is criticalto the life of the patient since hemodynamic losses from a cardiacpuncture can cause shock and death within minutes. Further, the outwardpressure that the puncture site is subjected to when it is located inthe heart muscle itself is much higher than puncture sites that aredistal to the heart. Accordingly, improved devices and methods forsecuring a prosthetic heart valve and for engaging and closing tissue,e.g., to close a cardiac puncture site, would be considered useful tosolve these and other problems known in the art.

SUMMARY

Apparatus and methods for anchoring a prosthetic heart valve aredescribed herein. In some embodiments, an apparatus includes a tetherattachment member that includes a base member that defines at least aportion of a tether passageway through which a portion of a tetherextending from a prosthetic heart valve can be received therethrough.The base member defines a locking pin channel that intersects the tetherpassageway. A locking pin is disposable within the locking pin channeland movable between a first position in which the locking pin is at aspaced distance from the tether passageway, and a second position inwhich the locking pin intersects the tether passageway and can engagethe portion of a tether disposed therein to secure the tether to thetether attachment member.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross-sectional illustration of portion of a heart with aprosthetic mitral valve implanted therein and an epicardial anchordevice anchoring the mitral valve in position.

FIG. 2 is a schematic illustration of an epicardial anchor device,according to an embodiment.

FIG. 3 is a side view of an epicardial anchor device, according to anembodiment.

FIG. 4 is an exploded side view of the epicardial anchor device of FIG.3.

FIG. 5 is a side view of the epicardial anchor device of FIG. 3 showndisposed at a spaced distance from a puncture site in an epicardialsurface of a ventricular wall and showing a sleeve gasket of theepicardial anchoring device in an uncompressed state or configuration.

FIG. 6 is a side view of the epicardial anchor device and ventricularwall of FIG. 5, shown with the anchoring device compressed against thepuncture site and ventricular wall and the gasket in a compressed stateor configuration.

FIG. 7 is an exploded side view of an epicardial anchor device,according to another embodiment.

FIG. 8 is an exploded side view of an epicardial anchor device,according to another embodiment.

FIG. 9 is a top view of a flexible pad that can be included in anepicardial anchor device, according to an embodiment.

FIG. 10 is a perspective view of the flexible pad of FIG. 9 and aportion of a tether disposed therethrough.

FIG. 11 is a perspective view of a locking pin and a tether attachmentmember, according to an embodiment.

FIG. 12 is a bottom perspective view of the tether attachment member ofFIG. 11.

FIG. 13 is a top perspective view of a tether attachment member that canbe used within an anchor device, according to an embodiment, with alever arm shown in a first position.

FIG. 14 is a cross-sectional perspective view of the tether attachmentmember of FIG. 13 with the lever arm shown in the first position.

FIG. 15 is a cross-sectional side view of the tether attachment memberof FIG. 13 with the lever arm shown in the first position and a portionof a tether extending through the device.

FIG. 16 is a cross-sectional side view of the tether attachment memberof FIG. 13 with the lever arm shown in a second position and a portionof a tether extending through the device.

FIG. 17 is a cross-sectional perspective view of a tether attachmentmember, according to an embodiment, with an access arm of the anchordevice shown in a first position and a portion of a tether extendingthrough the device.

FIG. 18 is a side-cross-sectional view of the tether attachment memberof FIG. 17 shown with the access arm in the first position and theportion of a tether extending through the device.

FIG. 19 is a perspective view of the tether attachment member of FIG. 17with a delivery device coupled thereto.

FIG. 20 is an enlarged view of the tether attachment member and aportion of the delivery device of FIG. 19.

FIG. 21 is a top perspective view of the tether attachment member ofFIG. 17 with the access arm shown in a second position.

FIG. 22 is a top perspective view of an epicardial anchor device,according to another embodiment.

FIG. 23 is a top view of the epicardial anchor device of FIG. 22.

FIG. 24 is an exploded view of the epicardial anchor device of FIG. 22.

FIG. 25 is a cross-sectional perspective view of the epicardial anchordevice of FIG. 22 with a locking pin of the device shown in a firstposition.

FIG. 26 is a cross-sectional side view of the epicardial anchor deviceof FIG. 20 with the locking pin of the device shown in the firstposition.

FIG. 27 is a cross-sectional bottom perspective view of the epicardialanchor device of FIG. 22 with the locking pin shown in a secondposition.

FIGS. 28 and 29 are a top perspective and a bottom perspective view,respectively, of a hub member of the epicardial anchor device of FIG.22.

FIG. 30 is an enlarged top view of a portion of the pericardial paddevice of FIG. 22.

FIG. 31 is a perspective view of the epicardial anchor device of FIG. 22with a delivery device coupled thereto.

DETAILED DESCRIPTION

Apparatus and methods are described herein that can be used for securingand anchoring a prosthetic heart valve, such as, for example, aprosthetic mitral valve. Apparatus and methods described herein can alsobe used to close openings through the heart formed for example, whenperforming a procedure to implant a prosthetic heart valve. Apparatusand methods described herein can also be used to anchor other medicaldevices and/or to close punctures or openings in other body lumensformed during a diagnostic or therapeutic procedure.

In some embodiments, an apparatus includes a tether attachment memberthat includes a base member that defines at least a portion of a tetherpassageway through which a portion of a tether extending from aprosthetic heart valve can be received therethrough. The base memberdefines a locking pin channel that intersects the tether passageway. Alocking pin is disposable within the locking pin channel and movablebetween a first position in which the locking pin is at a spaceddistance from the tether passageway, and a second position in which thelocking pin intersects the tether passageway and can engage the portionof a tether disposed therein to secure the tether to the tetherattachment member.

In some embodiments, an apparatus includes a tether attachment memberthat includes a base member and a lever arm movably coupled to the basemember. The base member and the lever arm collectively define a tetherpassageway through which a portion of a tether extending from aprosthetic heart valve can be received therethrough. The base memberdefines a locking pin channel that intersects the tether passageway andis in fluid communication therewith, and a locking pin is disposedwithin the locking pin channel. The lever arm is configured to be movedfrom a first position in which the portion of the tether can be insertedinto the tether passageway, and a second position in which the lockingpin secures a tether disposed within the tether passageway to the tetherattachment member.

In some embodiments, an apparatus includes a tether attachment memberthat includes a base member and a hub member rotatably coupled to thebase member. The base member and the hub each define at least a portionof a tether passageway through which a portion of a tether extendingfrom a prosthetic heart valve can be received therethrough. The basemember defines a locking pin channel that intersects the tetherpassageway and is in fluid communication therewith and a locking pin isdisposed at least partially within the locking pin channel. The hubdefines a cam channel in which a driver portion of the locking pin isreceived. The hub is configured to rotate relative to the base membersuch that the cam channel moves the locking pin linearly within thelocking pin channel moving the locking pin from a first position inwhich the locking pin is at a spaced distance from the tetherpassageway, and a second position in which the locking pin intersectsthe tether passageway and engages a portion of a tether disposed thereinto secure the tether to the tether attachment member.

In some embodiments, a method includes inserting into a tetherpassageway defined by a tether attachment member, a portion of a tetherextending from a prosthetic heart valve. The tether attachment member isdisposed adjacent an opening in a ventricular wall of a heart from whichthe tether extends. The tether attachment member is actuated such that alocking pin disposed within a locking pin channel defined by the tetherattachment member intersects the tether passageway and engages a portionof the tether disposed within the tether passageway, securing the tetherto the tether attachment member.

As used in this specification, the singular forms “a,” “an” and “the”include plural referents unless the context clearly dictates otherwise.Thus, for example, the term “a member” is intended to mean a singlemember or a combination of members, “a material” is intended to mean oneor more materials, or a combination thereof.

As used herein, the words “proximal” and “distal” refer to a directioncloser to and away from, respectively, an operator of, for example, amedical device. Thus, for example, the end of the medical device closestto the patient's body (e.g., contacting the patient's body or disposedwithin the patient's body) would be the distal end of the medicaldevice, while the end opposite the distal end and closest to, forexample, the user (or hand of the user) of the medical device, would bethe proximal end of the medical device.

In some embodiments, an epicardial pad system is described herein thatcan be used to anchor a compressible prosthetic heart valve replacement(e.g., a prosthetic mitral valve), which can be deployed into a closedbeating heart using a transcatheter delivery system. Such anadjustable-tether and epicardial pad system can be deployed via aminimally invasive procedure such as, for example, a procedure utilizingthe intercostal or subxyphoid space for valve introduction. In such aprocedure, the prosthetic valve can be formed in such a manner that itcan be compressed to fit within a delivery system and secondarilyejected from the delivery system into the target location, for example,the mitral or tricuspid valve annulus.

A compressible prosthetic mitral valve can have a shape, for examplethat features a tubular stent body that contains leaflets and an atrialcuff. This allows the valve to seat within the mitral annulus and beheld by the native mitral leaflets. The use of a flexible valve attachedusing an apical tether can provide compliance with the motion andgeometry of the heart. The geometry and motion of the heart arewell-known as exhibiting a complicated biphasic left ventriculardeformation with muscle thickening and a sequential twisting motion. Theadditional use of the apically secured ventricular tether helps maintainthe prosthetic valve's annular position without allowing the valve tomigrate, while providing enough tension between the cuff and the atrialtrabeculations to reduce, and preferably eliminate, perivalvularleaking. The use of a compliant valve prosthesis and the special shapeand features can help reduce or eliminate clotting and hemodynamicissues, including left ventricular outflow tract (LVOT) interferenceproblems. Many known valves are not able to address problems with bloodflow and aorta/aortic valve compression issues.

Structurally, the prosthetic heart valve can include: a self-expandingtubular frame having a cuff at one end (the atrial end); one or moreattachment points to which one or more tethers can be attached,preferably at or near the ventricular end of the valve; and a leafletassembly that contains the valve leaflets, which can be formed fromstabilized tissue or other suitable biological or synthetic material. Inone embodiment, the leaflet assembly may include a wire form where aformed wire structure is used in conjunction with stabilized tissue tocreate a leaflet support structure, which can have anywhere from 1, 2, 3or 4 leaflets, or valve cusps disposed therein. In another embodiment,the leaflet assembly can be wireless and use only the stabilized tissueand stent body to provide the leaflet support structure, and which canalso have anywhere from 1, 2, 3 or 4 leaflets, or valve cusps disposedtherein.

The upper cuff portion may be formed by heat-forming a portion of atubular nitinol structure (formed from, for example, braided wire or alaser-cut tube) such that the lower portion retains the tubular shapebut the upper portion is opened out of the tubular shape and expanded tocreate a widened collar structure that may be shaped in a variety offunctional regular or irregular funnel-like or collar-like shapes.

A prosthetic mitral valve can be anchored to the heart at a locationexternal to the heart via one or more tethers coupled to an anchordevice, as described herein. For example, the tether(s) can be coupledto the prosthetic mitral valve and extend out of the heart and besecured at an exterior location (e.g., the epicardial surface) with ananchor device, as described herein. An anchor device as described hereincan be used with one or more such tethers in other surgical situationswhere such a tether may be desired to extend from an intraluminal cavityto an external anchoring site.

FIG. 1 is a cross-sectional illustration of the left ventricle LV andleft atrium LA of a heart having a transcatheter prosthetic mitral valvePMV deployed therein and an epicardial anchor device EAD as describedherein securing the prosthetic mitral valve PMV in place. FIG. 1illustrates the prosthetic mitral valve PMV seated into the native valveannulus and held there using an atrial cuff AC of the prosthetic mitralvalve PMV, the radial tension from the native leaflets, and aventricular tether T secured with attachment portions Tp to theprosthetic mitral valve PMV and to the epicardial anchor EAD. Variousembodiments of an epicardial anchor device are described in more detailbelow with reference to specific embodiments.

FIG. 2 is a schematic illustration of an epicardial anchor device 100(also referred to herein as “anchor device” or “epicardial anchor”)according to an embodiment. The anchor device 100 can be used to anchoror secure a prosthetic mitral valve PMV deployed between the left atriumand left ventricle of a heart. The anchor device 100 can be used, forexample, to anchor or secure the prosthetic mitral valve PMV via asuturing tether 128 as described above with respect to FIG. 1. Theanchor device 100 can also seal a puncture formed in the ventricularwall (not shown in FIG. 2) of the heart during implantation of theprosthetic mitral valve PMV. The anchor device 100 can also be used inother applications to anchor a medical device (such as any prostheticatrioventricular valve or other heart valve) and/or to seal an openingsuch as a puncture.

The anchor device 100 can include a pad (or pad assembly) 120, a tetherattachment member 124 and a locking pin 126. In some embodiments, theanchor device 100 can include a sleeve gasket (not shown in FIG. 2) asdescribed with respect to FIGS. 3-6. The pad 120 can contact theepicardial surface of the heart and can be constructed of any suitablebiocompatible surgical material. The pad 120 can be used to assist thesealing of a surgical puncture formed when implanting a prostheticmitral valve. In some embodiments, the pad 120 can include a slot thatextends radially to an edge of the pad 120 such that the pad 120 can beattached to, or disposed about, the tether 128 by sliding the pad 120onto the tether 128 via the slot. Such an embodiment is described belowwith respect to FIGS. 9 and 10.

In some embodiments, the pad 120 can be made with a double velourmaterial to promote ingrowth of the pad 120 into the puncture site area.For example, pad or felt pledgets can be made of a felted polyester andmay be cut to any suitable size or shape, such as those available fromBard® as PTFE Felt Pledgets having a nominal thickness of 2.87 mm. Insome embodiments, the pad 120 can be larger in diameter than the tetherattachment member 124. The pad 120 can have a circular or disk shape, orother suitable shapes.

The tether attachment member 124 can provide the anchoring and mountingplatform to which one or more tethers 128 can be coupled (e.g., tied orpinned). The tether attachment member 124 can include a base member (notshown) that defines at least a portion of a tether passageway (notshown) through which the tether 128 can be received and pass through thetether attachment member 124, and a locking pin channel (not shown)through which the locking pin 126 can be received. The locking pinchannel can be in fluid communication with the tether passageway suchthat when the locking pin 126 is disposed in the locking pin channel,the locking pin 126 can contact or pierce the tether 128 as it passesthrough the tether passageway as described in more detail below withreference to specific embodiments.

The locking pin 126 can be used to hold the tether 128 in place afterthe anchor device 100 has been tightened against the ventricular walland the tether 128 has been pulled to a desired tension. For example,the tether 128 can extend through a hole in the pad 120, through a holein a sleeve gasket (if the anchor device includes a sleeve gasket), andthrough the tether passageway of the tether attachment member 124. Thelocking pin 126 can be inserted or moved within the locking pin channel134 such that it pierces or otherwise engages the tether 128 as thetether 128 extends through the tether passageway of the tetherattachment member 124. Thus, the locking pin 126 can intersect thetether 128 and secure the tether 128 to the tether attachment member124.

The tether attachment member 124 can be formed with, a variety ofsuitable biocompatible material. For example, in some embodiments, thetether attachment member 124 can be made of polyethylene, or other hardor semi-hard polymer, and can be covered with a polyester velour topromote ingrowth. In other embodiments, the tether attachment member 124can be made of metal, such as, for example, Nitinol®, or ceramicmaterials. The tether attachment member 124 can be various sizes and/orshapes. For example, the tether attachment member 124 can besubstantially disk shaped.

In some embodiments the tether attachment member 124 can include a leverarm (not shown in FIG. 2) that can be moved between an open position toload the tether 128 within the tether attachment member 124, and aclosed position to secure the tether 128 to the tether attachment member124. For example, in some embodiments, when the lever arm is moved tothe closed position, the tether passageway is brought into anintersecting relation with the locking pin channel such that the lockingpin 126 engages the tether 128 disposed within the tether passageway. Insome embodiments, when the lever arm is in the open position, a tool canbe used to move the locking pin within the locking pin channel such thatthe locking pin engages the tether 128 disposed within the tetherpassageway. In such an embodiment, after the locking pin 126 secures thetether 128, the lever arm can be moved to the closed position.

In some embodiments, the tether attachment member 124 can include a hubthat is movably coupled to the base member of tether attachment member124. The hub can define a channel that can receive a portion of thelocking pin (or locking pin assembly) 126 such that as the hub isrotated, the hub acts as a cam to move the locking pin 126 linearlywithin the locking pin channel. As with previous embodiments, as thelocking pin 126 is moved within the locking pin channel, the locking pincan engage or pierce the tether 128 disposed within the tetherpassageway and secure the tether 128 to the tether attachment member124. Such an embodiment is described herein with respect to FIGS. 22-31.

In use, after a PMV has been placed within a heart, the tether extendingfrom the PMV can be inserted into the tether passageway of the anchordevice 100 and the tension on the tether attachment device can beadjusted to a desired tension. Alternatively, in some cases, the tetherextending from the PMV can be coupled to the anchor device 100 prior tothe PMV being placed within the heart. The anchor device 100 (e.g., someportion of the anchor device such as the tether attachment member 124,or the lever arm or hub depending on the particular embodiment) can beactuated such that the locking pin 126 intersects the tether passagewayand engages a portion of the tether disposed within the tetherpassageway, securing the tether to the tether attachment member. In someembodiments, prior to inserting the tether into the tether passageway,the anchor device 100 can be actuated to configure the anchor device 100to receive the tether. For example, if the tether attachment memberincludes a lever arm movably coupled to the base member, the lever armmay need to be moved to an open position to allow the tether to beinserted. In some embodiments, the anchor device 100 can be actuated byrotating a hub relative to a base member of the tether attachment member124 such that the locking pin 126 is moved from a first position inwhich the locking pin is spaced from the tether passageway and a secondposition in which the locking pin intersects the tether passageway andengages or pierces the portion of the tether.

One implementation of the epicardial anchor device 100 is shown in FIGS.3-6. An epicardial anchor device 200 (also referred to herein as “anchordevice” or “epicardial anchor”) can include a flexible pad 220, a sleevegasket 222, a tether attachment member 224 and a locking pin 226 (shownin FIG. 4). The anchor device 200 can be used to anchor or secure aprosthetic mitral valve (not shown in FIGS. 3-6) via a suturing tether228 shown in FIGS. 5 and 6. The anchor device 200 can also seal apuncture 230 formed in the ventricular wall V (see FIGS. 5 and 6) of theheart during implantation of the prosthetic mitral valve.

The flexible pad 220 (also referred to herein as “pad”) can contact theepicardial surface of the heart and can be constructed of any suitablebiocompatible surgical material. The pad 220 can be used to assist thesealing of a surgical puncture (e.g., puncture 230) formed whenimplanting a prosthetic mitral valve. The pad 220 can be made with thesame or similar materials as described above for pad 120, and can bevarious sizes and shapes. The pad 220 is shown as having a circular ordisk shape, however it should be understood that other suitable shapescan alternatively be used. The pad 220 defines a hole 225 (see FIGS. 4and 6) through which the tether 228 (shown in FIGS. 5 and 6) can bereceived as described in more detail below.

The sleeve gasket 222 can be disposed between the pad 220 and the tetherattachment member 224 and can be used to seal a gap or leakage that mayoccur between the pad 220 and the tether attachment member 224. Thesleeve gasket 222 can be made of, for example, a flexible material suchthat it can be compressed when the tether attachment member 224 and/orpad 220 are tightened against the puncture site, e.g. against theventricular wall. The sleeve gasket 222 may be a separate componentcoupled to the pad 220 and the tether attachment member 224 or can beformed integrally or monolithically with the pad 220 and/or the tetherattachment member 224. The sleeve gasket 222 can be used to preventhemodynamic leakage that may flow along the path of the suturing tether228. The sleeve gasket 222 can also define a hole (not shown) throughwhich the tether 228 can be received.

The tether attachment member 224 can provide the anchoring and mountingplatform to which one or more tethers 228 (see FIGS. 5 and 6) may becoupled (e.g., tied). The tether attachment member 224 includes a basemember 240 that defines an axial tether passageway 235 through which thetether 228 can be received and pass through the tether attachment member224, and a locking pin channel 234 through which the locking pin 226 canbe received. The locking pin channel 234 can be in fluid communicationwith the tether passageway 235 such that when the locking pin 226 isdisposed in the locking pin channel 234, the locking pin 226 can contactthe tether 228 as it passes through the tether passageway 235 asdescribed in more detail below. The locking pin 226 can be used to holdthe tether 228 in place after the anchor device 200 has been tightenedagainst the ventricular wall V. For example, the tether 228 can extendthrough the hole 225 of the pad 220, through the hole (not shown) of thesleeve gasket 222, and through the tether passageway 235 of the tetherattachment member 224. The locking pin 226 can be inserted through thelocking pin channel 234 such that it pierces the tether 228 as thetether 228 extends through the tether passageway 235 of the tetherattachment member 224. Thus, the locking pin 226 can laterally intersectthe tether 228 and secure the tether 228 to the tether attachment member224.

The tether attachment member 224 can be made of any suitablebiocompatible material. For example, in some embodiments, the tetherattachment member 224 can be made of polyethylene, or other hard orsemi-hard polymer, and can be covered with a polyester velour to promoteingrowth. In other embodiments, the tether attachment member 224 can bemade of metal, such as, for example, Nitinol®, or ceramic materials. Thetether attachment member 224 can be various sizes and/or shapes. Forexample, the tether attachment member 224 can be substantially diskshaped.

In some embodiments, the tether attachment member 224 can besubstantially disk shaped and have a diameter between, for example,1.0-3.0 cm. In other embodiments, the tether attachment member 224 canhave a diameter, for example, between 0.2-5.0 cm. For example, a largersize tether attachment member 224 may be desirable to use in, forexample, a hernia repair, gastrointestinal repairs, etc.

The disk shape of the tether attachment member 224 used to capture andanchor a suture can also be used with little or no trauma to the tissueat the site of the anchor, unlike suture anchors that bore into tissuewith screws or barbs. Further, the disk shaped tether attachment member224 can be easily and quickly slid over the tether 228, instead of usingstitches, which can allow for the effective permanent closure of largepunctures. Surgically closing large punctures by sewing can be timeconsuming and difficult. When closing a puncture in the heart, addingthe difficulty of requiring a surgeon to sew the puncture closed canincrease the likelihood of life threatening complications to thepatient. This is especially so in a situation where a prosthetic heartvalve is delivered and deployed without opening the chest cavity usingtranscatheter technologies. Sewing a ventricular puncture closed in thissituation may be undesirable.

FIGS. 5 and 6 illustrate the tether 228 extending through the puncturesite 230 within a left ventricular wall V of a heart and coupled to theanchor device 200. FIG. 5 illustrates the anchor device 200 prior tobeing tightened against the epicardial surface of the ventricular wallV, and the sleeve gasket 222 in an uncompressed state or configuration.The tether 228 can optionally be wound around the tether attachmentmember 224 to further improve anchoring.

FIG. 6 illustrates the anchor device 200 tightened against theepicardial surface of the ventricular wall V. As shown in FIG. 6, theanchor device 200 can be compressed against the puncture site 230 andcontact the epicardial surface. An end portion 232 (shown in FIG. 5) ofthe tether 228 can be trimmed after the tether 228 has been secured tothe tether attachment member 224 or after the anchor device 200 has beensecured against the epicardial surface.

FIG. 7 illustrates an embodiment of an epicardial anchor device 300(also referred to herein as “anchor device” or “epicardial anchor”) thatis similar to the anchor device 200 except the anchor device 300 doesnot include a sleeve gasket (e.g., sleeve gasket 222 described above).The anchor device 300 can include a flexible pad 320, a tetherattachment member 324 and a locking pin 326, which can be configured thesame as or similar to the flexible pad 220, the tether attachment member224 and the locking pin 226, respectively, described above. The anchordevice 300 can be used the same as or similar to anchor device 200 tosecure a prosthetic mitral valve (not shown) via a suturing tether (notshown). The anchor device 300 may be desirable to use, for example, whenan anti-leakage sleeve is unnecessary to prevent hemodynamic leakagethat may flow along the path of the suturing tether.

FIG. 8 illustrates an embodiment of an epicardial anchor device 400(also referred to herein as “anchor device” or “epicardial anchor”) thatis similar to the anchor device 200 and the anchor device 300 except theanchor device 400 does not include a pad (e.g., pads 220 and 320). Theanchor device 400 can include a tether attachment member 424, a sleevegasket 422 and a locking pin 426, which can be configured the same as orsimilar to the tether attachment member 224, the sleeve gasket 222 andthe locking pin 226, respectively, described above. The anchor device400 can be used to anchor or secure a prosthetic mitral valve (notshown) via a tether (not shown) in the same or similar manner asdescribed above for previous embodiments. The anchor device 400 may bedesirable to use, for example, when a flexible pad is unnecessary, forexample, when the tether is moved to a new location. In such a case, theventricular puncture would be small (e.g., a small diameter) and may notrequire the pad for bleeding control.

FIGS. 9 and 10 illustrate an embodiment of a pad 520 that can beincluded in an epicardial anchor device as described herein. The pad 520defines an axial hole 525 and a slot 537 that communicates with hole525. The slot 537 extends radially to an outer edge of the pad 520 suchthat the pad 520 can be disposed about or removed from a tether 528 (seeFIG. 10) without sliding the pad 520 down the length of tether 528. Forexample, the pad 520 can be disposed about the tether 528 by laterallysliding the pad 520 from the side such that the tether is inserted intothe slot 537 and positioned within the opening 525 of the pad 520. Thepad 520 can be secured to the tether with, for example, pins, clamps,etc.

To remove the pad 520, the pad 520 can similarly slide off from theside, for example, outside of the apex of the ventricle of the heart.Thus, the pad 520 can be removed without removing the entire anchordevice. The pad 520 can be formed with the same or similar materials asdescribed above for previous embodiments (e.g., pad 220, 320, 420), andcan be used to close a puncture site (e.g., in a ventricular wall) asdescribed above.

The pad 520 can also enable the use of an introducer sheath at the apex,which would limit the amount of motion and passes through the apex. Forexample, when the sheath is pulled back, a slotted pad 520 can be slidin from the side allowing control of the tether tension during sheathremoval. The pad 520 with slot 537 can also be used independent of asheath as described above.

FIGS. 11 and 12 illustrate an embodiment of a tether attachment member624 that can be included within an anchor device as described herein.Various features described herein for tether attachment member 624 canalso be included in the tether attachment members described herein forother embodiments (e.g., 124, 224, 324, 424). As described above, alocking pin 626 (shown in FIG. 11) can be used to secure a tether/sutureto the tether attachment member 624 in a similar manner as describedabove for previous embodiments.

The tether attachment member 624 is shown having a disk shape and caninclude a base member 640 that defines a winding channel 632, an axialtether passageway 635, radial channels 633, and a locking pin channel634 through which the locking pin 626 can be received. The base member640 also defines a proximal opening 615 and a distal opening 617 eachcommunicating with the tether passageway 835. The base member 640 caninclude a chamfered edge or lead-in portion 627 at the proximal opening615, and a chamfered edge or lead-in portion 629 at the distal opening617 to allow a suture (e.g., tether) to be easily threaded into thetether passageway 635 and reduce lateral cutting force of the tetherattachment member 624 against the suture. The radial channels 633 canallow a user to quickly capture and seat a tether (not shown) that isintended to be anchored. The winding channel 632 can allow a user toquickly wind tether(s) around tether attachment member 624. The use ofwinding channel 632 with radial channel(s) 633 can allow a user toquickly anchor the tether while permitting the user to unwind andrecalibrate the anchor device to adjust the tension on the tether (notshown) as appropriate for a particular use.

FIGS. 13-16 illustrate a portion of another embodiment of an epicardialanchor device 700. The epicardial anchor device 700 includes a tetherattachment member 724 and a flexible pad or fabric member (not shown inFIGS. 13-16). The tether attachment member 724 includes a base member740 that defines a locking pin channel 734 that can receive therein alocking pin 726 in a similar manner as described above for previousembodiments and a circumferential pad channel 742. The pad channel 742can be used to secure the flexible pad or fabric member (not shown inFIGS. 13-16) of the epicardial anchor device 700 to the tetherattachment member 724. For example, the flexible pad can be disposed ona distal end portion of the tether attachment member 724 such that whenthe anchor device 700 is secured to a ventricular wall as describedabove for previous embodiments, the flexible pad contacts theventricular wall.

The tether attachment member 724 also defines tether passageway 735through which a tether 728 (see, e.g., FIGS. 15 and 16) can be received,and a proximal opening 715 and a distal opening 717 each incommunication with the tether passageway 735. A chamfered edge orlead-in portion 729 is included at or near the distal opening 717 toallow a tether 728 (see e.g., FIGS. 15 and 16) to be easily threadedinto the tether passageway 735 and reduce lateral cutting force of thetether attachment member 724 against the tether 728.

A lever arm 738 is coupled to the base member 740 that collectively withthe base member 740 defines a tether passageway 735. The lever arm 738can be moved between a first position, as shown in FIG. 16, in which thelever arm 738 is biased by a spring member 739 into a down position, anda second position, as shown in FIGS. 13-15, in which the lever arm 738is placed in an extended position to allow the tether 728 to be placedwithin the tether passageway 735. For example, the lever arm 738 can berotated in the direction of arrow A shown in FIG. 15 to move the leverarm 738 to its second or extended position. In some cases, a suture orcord can be used to pull the lever arm 738 to the extended secondposition.

When in the first position, as shown, for example, in FIGS. 14 and 15, atip of the locking pin 726 is disposed at a spaced distance from thelever arm 738 and the tether passageway 735. When the locking pin 726 isspaced from the tether passageway 735, the tether 728 can be insertedinto the tether passageway 735 as shown in FIG. 15. The tether 728 canthen be tightened to a desired tension and the lever arm can then bereleased such that it is biased back to the first position, as shown inFIG. 16. When the lever arm 738 is moved (e.g., biased) to the firstposition, and with the tether 728 extending through the tetherpassageway 735, the locking pin 726 pierces or intersects with thetether 728 and the tip of the locking pin is then disposed within acavity 736 defined by the lever arm 738 securing the tether 728 to thetether attachment member 724.

FIGS. 17-21 illustrate a portion of another embodiment of an epicardialanchor device 800 that includes a tether attachment member 824 and aflexible pad or fabric member (not shown in FIGS. 17-21). The tetherattachment member 824 includes a base member 840 and a lever arm 838pivotally coupled to the base member 840. The base member 840 defines acircumferential pad channel 842 in which the flexible pad can be coupledto the tether attachment member 824. For example, the flexible pad canbe disposed on a distal end portion of the tether attachment member 824such that when the anchor device 800 is secured to a ventricular wall asdescribed above for previous embodiments, the flexible pad contacts theventricular wall.

The lever arm 838 and the base member 840 collectively define a tetherpassageway 835 through which a tether 828 can be received, as shown inFIG. 17. The base member 840 also defines a distal opening 817 and anopening 815 each in fluid communication with the tether passageway 835.The tether 828 can be inserted through the distal opening 817 (the sideto be implanted closest to the ventricular wall) and extend through aportion of the tether passageway 835 defined by the base member 840, andthrough a portion of the tether passageway 835 defined by the lever arm838, and exit the opening 815. As with previous embodiments, the basemember 840 includes a chamfered edge or lead-in portion 829 at thedistal opening 817 of the tether passageway 835 to allow the tether 828to be easily threaded into the tether passageway 835 and reduce lateralcutting force of the tether attachment member 824 against the tether828.

The lever arm 838 defines a locking pin channel 844 in which a lockingpin 826 can be movably disposed. The locking pin 826 includes a driverportion 846 and a piercing portion 849. As shown in FIGS. 17 and 18, thelocking pin channel 844 includes portions with varying diameters inwhich the driver portion 846 of the locking pin 826 can be movablydisposed. For example, the driver portion 846 can be threadably coupledto the inner walls of the locking pin channel 844 such that the lockingpin 826 can be moved between a first position, shown in FIG. 17, inwhich the driver portion 846 is disposed within a portion 839 of thelocking pin channel 844 and the piercing portion 849 is spaced from thetether passageway 835, and a second position in which the driver portion846 is disposed within a portion 845 (shown in FIGS. 17 and 18) of thelocking pin channel 834, and the piercing portion 849 extends throughthe tether passageway 835, engaging or piercing the tether 828. Thelever arm 838 also defines an opening 847 that communicates with thelocking pin channel 844 and can receive a driving tool that can be usedto move the locking pin 826 within the locking pin channel 844 asdescribed in more detail below.

The lever arm 838 can be moved (e.g., rotated, pivoted) between a firstor open position, as shown, for example, in FIGS. 17 and 18, in whichthe lever arm 838 extends in a proximal direction from the base member840, and a second or closed position as shown in FIG. 21, in which aproximal surface 819 of the lever arm 838 is substantially flush with aproximal surface 821 of the base member 840. When the lever arm 838 isin the first or open position, a delivery tool 848 can be coupled to thelever arm 828 as shown in FIGS. 19 and 20. The delivery tool 848 caninclude a driver 849 shown in FIG. 18 (e.g., a screw driver) that canengage the driver portion 846 of the locking pin 826 to move the lockingpin 826 within the locking pin channel 834.

In operation, the tether 828 can be inserted into the tether passageway835 and extend out of the opening 815 and within the delivery tool 848.The tether 828 can then be tightened to a desired tension. With thetether 828 at the desired tension, the driver 849 of the delivery tool848 can then move the locking pin 826 from the first position, as shownin FIG. 17 to the second position in which the piercing portion 849pierces or engages the tether 828, securing the tether 828 to the tetherattachment member 824. For example, the driver 849 of the delivery tool848 can threadably move the locking pin 826 from the first position tothe second position. After the tether 828 is secured to the tetherattachment member 824, the delivery tool 849 can be removed and thelever arm 838 can be moved to the second or closed position as shown inFIG. 21.

FIGS. 22-30 illustrate an epicardial anchor device according to anotherembodiment. An epicardial anchor device 900 includes a tether attachmentmember 924, a pad assembly 920, a tube member 955 and a tube covermember 956. The tether attachment member 924 includes a base member 940,a hub 950, a retaining ring 952, a locking pin assembly 926, and a pinmember 953. The locking pin assembly 926 includes a driver portion 946and a piercing portion 949. The base member 940 defines acircumferential pad channel 942, a retaining channel 951 and a lockingpin channel 934. The pad channel 942 can be used to couple the padassembly 920 to the tether attachment member 924. The retaining channel951 can receive an outer edge of the retaining ring 952, which is usedto retain the hub 950 to the base member 940. The base member 940 alsodefines cutouts or detents 943, as shown for example, in FIGS. 23, 25and 30.

The tube member 955 is coupled to the base member 940 and the basemember 940, the hub 950 and the tube member 955 collectively define atether passageway 935 through which a tether (not shown) can bereceived. The cover member 956 can be formed with a fabric material,such as for example, Dacron®. The tether channel 935 intersects thelocking pin channel 934 and is in fluid communication therewith.

The pad assembly 920 includes a top pad portion 958, a bottom padportion 959 and a filler member 957 disposed therebetween. The top padportion 958 and the bottom pad portion 959 can each be formed with, forexample, a flexible fabric material. The top pad portion 958 and thebottom pad portion 959 can each define a central opening through whichthe tube member 955 can pass through. A portion of the top pad portion958 is received within the channel 942 of the base member 940 as shown,for example, in FIGS. 25-27.

An outer perimeter portion of the hub 950 is received within theretaining channel 951 such that the hub 950 can rotate relative to thebase member 940 to actuate the locking pin assembly 926 as described inmore detail below. As shown, for example, in FIGS. 28 and 29, the hub950 includes arms 961 with protrusions 962. The protrusions 962 can bereceived within cutouts 943 of the base member 940 and act as a stop orlimit to the rotation of the hub 950. The slots 963 defined by the hub950 enable the arms 961 to flex and allow the protrusions 962 to bemoved in and out of the cutouts 943. As shown, for example, in FIGS. 27and 29 the hub 950 defines a curved channel 950 on a bottom portion ofthe hub 950. The curved channel 950 is asymmetrical (or spiral) andreceives the driver portion 946 of the locking pin assembly 926. As thehub 950 is rotated relative to the base member 940, the hub 950 acts asa cam to move the locking pin assembly 926 linearly within the lockingpin channel 934. The locking pin assembly 926 can be moved from a firstposition in which the piercing portion 949 is disposed outside of thetether passageway 935 as shown in FIGS. 25 and 26, and a second positionin which the piercing portion 949 extends through the tether passageway935 as shown in FIG. 27. The pin member 953 (see, e.g., FIG. 26) can beformed with a metal material that is more radio-opaque than the othercomponents of the anchor device and thus visible to the user (e.g.physician) using conventional imaging modalities to enable the user toconfirm that the locking pin assembly 926 has been fully moved to thesecond position.

In use, when the locking pin assembly 926 is in the first position, atether (not shown) coupled to, for example, a prosthetic mitral valveand extending through a puncture site in the ventricular wall of a heartcan be inserted through the tether passageway 935. The hub 950 can thenbe rotated 180 degrees to move the locking pin assembly 926 linearlywithin the locking pin channel 934 such that the piercing portion 949extends through the tether passageway 935 and engages or pierces thetether, securing the tether to the tether attachment member 924. Forexample, when the locking pin is in the first position, the protrusions962 of the hub 950 are each disposed within one of the cutouts 943 ofthe base member 940 (i.e., a first protrusion is in a first cutout, anda second protrusion is in a second cutout). The hub 950 can then berotated 180 degrees such that the protrusions 962 are moved out of thecutouts 943 of the base member 940 and at the end of the 180 degrees theprotrusions 962 are moved into the other of the cutouts 943 of the basemember 940 (i.e., the first protrusion is now in the second cutout, thesecond protrusion is now in the first cutout).

The base member 940 can also include cutout sections 966 and define sideopenings 967 (see, e.g., FIGS. 22 and 23) that can be used to couple adelivery device to the epicardial anchor device 900. For example, FIG.31 illustrates a delivery device 948 having coupling arms 968 andcoupling pins (not shown) extending inwardly from the arms 968. The sideopenings 967 can receive the coupling pins and the cutout sections 966can be engaged by the coupling arms 968.

While various embodiments have been described above, it should beunderstood that they have been presented by way of example only, and notlimitation. Where methods described above indicate certain eventsoccurring in certain order, the ordering of certain events may bemodified. Additionally, certain of the events may be performedconcurrently in a parallel process when possible, as well as performedsequentially as described above

Where schematics and/or embodiments described above indicate certaincomponents arranged in certain orientations or positions, thearrangement of components may be modified. While the embodiments havebeen particularly shown and described, it will be understood thatvarious changes in form and details may be made. Any portion of theapparatus and/or methods described herein may be combined in anycombination, except mutually exclusive combinations. The embodimentsdescribed herein can include various combinations and/orsub-combinations of the functions, components, and/or features of thedifferent embodiments described.

1. A method of securing a prosthetic heart valve to a heart, the method comprising: inserting a portion of a tether into a tether passageway defined by a tether attachment member, the tether extending from the prosthetic heart valve; disposing the tether attachment member adjacent an opening in a ventricular wall of the heart from which the tether extends; and actuating the tether attachment member such that a locking pin disposed within a locking pin channel defined by the tether attachment member intersects the tether passageway and engages a portion of the tether disposed within the tether passageway, securing the tether to the tether attachment member.
 2. The method of claim 1, further comprising: prior to actuating the tether attachment member, adjusting the tension of the tether extending through the tether passageway to a desired tension.
 3. The method of claim 1, wherein the tether attachment member includes a base member and a lever arm movably coupled to the base member, and actuating the tether attachment member includes moving the lever arm relative to the base member from a first position in which the tether can be inserted into the tether passageway to a second position in which the locking pin intersects the tether passageway and engages the portion of the tether.
 4. The method of claim 1, wherein the tether attachment member includes a base member and a hub rotatably coupled to the base member, a portion of the locking pin being received within a locking pin channel defined by the hub, and actuating the tether attachment member includes rotating the hub relative to the base member such that the hub moves the locking pin linearly within the locking pin channel from a first position in which the locking pin is spaced from the tether passageway to a second position in which the locking pin intersects the tether passageway and engages the portion of the tether.
 5. The method of claim 4, wherein the base member has a retaining channel, and the hub has an outer perimeter portion received within the retaining channel.
 6. The method of claim 4, wherein the base member and the hub each define at least a portion of the tether passageway.
 7. The method of claim 4, wherein the locking pin channel intersects the tether passageway at a transverse angle and is in fluid communication therewith.
 8. The method of claim 4, wherein a bottom portion of the hub defines a curved channel in which a driver portion of the locking pin is received.
 9. The method of claim 7, wherein rotating the hub relative to the base member moves the driver portion of the locking pin along the curved channel.
 10. The method of claim 4, further comprising contacting the ventricular wall with a pad coupled to the tether attachment member so that the pad is disposed between the ventricular wall and the tether attachment member.
 11. The method of claim 4, wherein a tube member is coupled to the base member, the tube member defining a portion of the tether passageway.
 12. The method of claim 11, wherein a cover member is disposed over the tube member.
 13. The method of claim 4, wherein the base member defines a detent configured to receive therein a protrusion on the hub to limit the rotation of the hub relative to the base member.
 14. The method of claim 4, further comprising engaging coupling arms of a delivery device to cutout sections in the base member.
 15. The method of claim 14, further comprising engaging coupling pins extending from the coupling arms of the delivery device with side openings defined within the cutout sections of the base member.
 16. The method of claim 15, further comprising adjusting the tension of the tether using the delivery device while the delivery device is engaged to the base member.
 17. The method of claim 16, wherein actuating the tether attachment member is performed after adjusting the tension of the tether. 